Use of vibegron to treat overactive bladder

Abstract

The present disclosure is directed to a method of treating overactive bladder comprising orally administering to a subject in need thereof an amount of from about 60 mg to about 90 mg (e.g., about 75 mg) of vibegron per day. The present disclosure is also directed to a pharmaceutical unit dosage composition comprising from about 60 mg to about 90 mg (e.g., about 75 mg) of vibegron for oral administration.

1 . A method of treating overactive bladder, the method comprising orally administering to a subject in need thereof an amount of from about 60 mg to about 90 mg of vibegron per day. 
     
     
         2 . The method of  claim 1 , wherein the amount of vibegron is about 65 mg to about 85 mg. 
     
     
         3 . The method of  claim 1 , wherein the amount of vibegron is about 70 mg to about 80 mg. 
     
     
         4 . The method of  claim 1 , wherein the amount of vibegron is about 75 mg. 
     
     
         5 . The method of  claim 1 , wherein the subject has a symptom selected from the group consisting of urgency urinary incontinence, urinary urgency, urinary frequency, or a combination thereof. 
     
     
         6 . The method of  claim 5 , wherein the subject has the symptoms urgency urinary incontinence, urinary urgency, and urinary frequency. 
     
     
         7 . The method of  claim 1 , wherein the subject is a human. 
     
     
         8 . The method of  claim 7 , wherein the human is a female. 
     
     
         9 . The method of  claim 7 , wherein the human is a male. 
     
     
         10 . The method of  claim 7 , wherein the human is over the age of 65 years. 
     
     
         11 .- 27 . (canceled) 
     
     
         28 . A pharmaceutical unit dosage composition comprising from about 60 mg to about 90 mg vibegron, wherein the unit dosage composition is suitable for oral administration. 
     
     
         29 . The pharmaceutical unit dosage composition of  claim 28 , wherein the unit dosage composition comprises from about 65 mg to about 85 mg vibegron. 
     
     
         30 . The pharmaceutical unit dosage composition of  claim 28 , wherein the unit dosage composition comprises from about 70 mg to about 80 mg vibegron. 
     
     
         31 . The pharmaceutical unit dosage composition of  claim 28 , wherein the unit dosage composition comprises about 75 mg vibegron. 
     
     
         32 . A method of preparing a pharmaceutical unit dose comprising from about 60 mg to about 90 mg vibegron, wherein the method comprises one or more of wet granulation, wet milling, fluid bed drying, dry milling, lubrication, tableting, or aqueous film coating. 
     
     
         33 . The method of  claim 32 , wherein the pharmaceutical unit dose is an oral dosage form. 
     
     
         34 . The method of  claim 33 , wherein the method further comprises combining vibegron with a pharmaceutically acceptable excipient. 
     
     
         35 . The method of  claim 34 , wherein the pharmaceutically acceptable excipient is selected from lactose, microcrystalline cellulose, starch, calcium carbonate, magnesium stearate, stearic acid, talc, colloidal silicon dioxide, mannitol, croscarmellose sodium, or hydroxypropyl cellulose.